Artificial cutaneous stoma

ABSTRACT

A device for providing a long term percutaneous pathway for elongated members such as catheters, pacemaker leads, fiber optics, and the like, comprising a flanged cup-shaped body containing coils of the elongated member or members and having tissue fixation means on its surface, at least one aperture in the bottom of the body through which the elongated members pass and to which the elongated member may be permanently affixed and a membranous cover designed to be cut along with overlying skin for withdrawal of the coiled portion of the elongated member after cutaneous implantation and healing.

United States Patent [1 1 Newash ARTIFICIAL CUTANEOUS STOMA Mahmoud S. Newash, Saginaw, Mich.

[731 Assignee: Dow Corning Corporation, Midland,

Mich.

[22] Filed: Apr. 10, 1972 [21] Appl. No.2 242,505

[75] Inventor:

3,699,956 10/1972 Kitrilaris et al. 128/348 Primary ExaminerDalton L. Truluck Attorney-Robert F. Fleming, .lr., Howard W. Hermann et al.

[57] ABSTRACT A device for providing a long term per-cutaneous pathway for elongated members such as catheters, pacemaker leads, fiber optics, and the like, comprising a flanged cup-shaped body containing coils of the elongated member or members and having tissue fixation means on its surface, at least one aperture in the bottom of the body through which the elongated members pass and to which the elongated member may be permanently afi'ixed and a membranous cover designed to be cut along with overlying skin for withdrawal of the coiled portion of the elongated member after cutaneous implantation and healing.

10 Claims, 3 Drawing Figures 1 ARTIFICIAL CUTANEOUS STOMA BACKGROUND OF THE INVENTION The present invention relates to the field of surgically implantable skin exit devices for elongated members such as catheters, pacemaker leads, fiber optics, and the like.

In various surgical procedures it has become a common practice to permanently implant an elongated member such as a catheter, a pacemaker lead, a fiber optic element, and similar devices in a manner such that one end of the elongated member remains in position within the body on a long-term or permanent basis and the other end must be passed through the skin to some type of external device. For example, in the case of a chronic renal malfunction permanently indwelling cannulae are provided for extracorporeal hemodialysis. Similarly, electrical conductors such as heart pacer leads are permanently implanted for purpose of interconnecting an internal organ with an external power source or monitoring device.

The primary problems associated with long-term indwelling of percutaneous leads and catheters have been infection introduced at the point of exit from the skin of the device and displacement of the device. The infection is caused by migration of microorganisms from the point of exteriorization of the device. The displacement can mean loss of proper position of the implanted end of the device as well as increased infection as the device slides back and forth through the skin exit. It is toward these problems of the prior art that the present invention is directed.

SUMMARY OF THE INVENTION It is a primary object of the present invention to provide a means for permanent access to the inner body through the skin which reduces or eliminates the problems heretofore prevalent in many such devices. In accordance with this and other objects there is provided by the present invention a device for providing a longterm percutaneous pathway for elongated members such as catheters, pacemaker leads, fiber optics, and

similar devices and is useful generally in any applica-' tion that requires repeated transfer of substances between intracorporeal and extracorporeal environments or which requires transfer of energies such as electricity, heat, light, etc. between these environments. In its simplest form the invention comprises a flanged cupshaped body which contains coils of the elongated member and has tissue fixation means on its external surface. However, this device is not limited to a cupshaped device. Any form can be employed so long as it provides a sealed housing to accommodate the coiled portion of the elongated member of this device. An aperture in the bottom of the cup-shaped body allows the elongated member to pass intracorporeally. The elongated member may be permanently affixed to the bottom of the cup. A membranous cover is designed to be cut along with the overlying skin for withdrawal of the coiled portion of the elongated member subsequent to the cutaneous implantation and healing of the incision made for implantation. The device is designed to be initially implanted totally beneath the skin and after substantial healing has taken place an incision is made through the overlying skin and through the cover of the device to expose the coiled length of catheter or other elongated member contained therein. The small incision required and the viability of the tissue surrounding the incision will minimize migration of microorganisms during the most critical period. Even if immediate exteriorization of the indwelling elongated member is required at the time of implantation the design of the device of the present invention together with proper surgical techniques as discussed below guard in marked manner against infection and sharply reduces incidents of trauma and displacement. The cup-shaped body may be filled with a room temperature vulcanizable silicone rubber or suitable material after the elongated member coiled therein has been exteriorized, thus further blocking passage of infectious organisms.

Other objects and advantages of the present invention will become clear to those skilled in the art from a reading of the following detailed description when read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view in perspective of an artificial cutaneous stoma made in accordance with the present invention.

FIG. 2 is a vertical cross-section of the device shown in FIG. 1.

FIG. 3 is a vertical cross-section of the device shown in FIGS. 1 and 2 after exteriorization of the device has been accomplished.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings wherein like reference numerals designate like parts throughout the figures thereof, there is shown in FIG. 1 a device for providing a long-term percutaneous pathway which comprises a flanged cup-shaped body 11 with the flange 12 positioned around the top thereof. The body 11 including the flange 12 are preferably made of a physiologically inert flexible substance such as silicone rubber. A membranous cover 13 is provided over the open end of the body 1 l. The flange l2 and the membranous cover 13 may be a unitary element or separate parts. The cover may also be made of silicone rubber which is adhesively secured in its peripheral areas to the top surface of the flange 12. An artificial stroma (tissue ingrowth means) 14 which may, for example, be a Dacron mesh, a felt, or a tissue-permeable open cell foam, are provided on the surface of the body ll, preferably on both the cup-shaped portion and the flange portions thereof. The artificial stroma (tissue ingrowth means) 14 serves to securely anchor the device in position and also to allow growth of tissue intimately with the device to deter the ingress of infection.

The elongated member 16 which is designed to be passed percutaneously has one end thereof coiled within the cup-shaped portion 11 and the other end thereof passing through and preferably permanently attached to the bottom of the cup-shaped portion at 17. The member 16 may be a catheter, an electrically conductive element, or a fiber optic element, for example, and in general may be any kind of elongated member useful for transfer of substances between intracorporeal and extracorporeal environments or which is useful for transfer of energy such as electricity, heat, light, etc. between such environments. The elongated member 16 may be a single tube or element or it may be two or more such elements as in the case of electrical leads in a heart pace control device. It should be understood, of course, that the surface of such elongated element must also be of a material which is compatible with body tissue. Again a silicone rubber material is preferred for the surface of the elongated body.

For operation of the device the extended portion of the elongated member 16 is surgically positioned as required within the body and the cup-shaped body 11 is surgically implanted, for example, using a blunt subcutaneous disection. Preferably a U-shaped skin incision is utilized so that a skin flap may be placed over the device and sutured such that the suture line is distant from and not on the device. Preferably, several days postoperatively a second skin incision is made directly over the cup-shaped body 11 of the device. The incision is made as small as possible but must extend through the overlying skin flap and the closure membrane 13 directly over the cup-shaped body 11 in order that the coiled end of the elongated member 16 can be exteriorized through the incision. The exteriorized portion of the elongated member can then be connected to the necessary extracorporeal equipment to be associated with the device. It is to be understood that if necessary because of medical urgency the coiled portion of the lead contained within the cup-shaped portion'of the device can be exteriorized at the time of the initial surgical procedure where the extended portion of the member 16 is implanted intracorporeally; however, by waiting until substantial healing has taken place the danger of infection is minimized and the danger of displacement of the intracorporeal portion of the device is also minimized. After the exteriorization of the portion of the elongated member or members 16 coiled within the cup-shaped body 11, the cup-shaped body 11 may be filled with an inert non-permeating permanently flexible material such as room temperature vulcanizable silicone rubber or other suitable material to eliminate the creation of a subcutaneous pocket or void.

Various modifications of the device as described hereinabove are within the skill of those versed in the art. For example, instead of the device having a tubular member 17 extending from the bottom thereof through which the elongated member 16 is telescopingly positioned, the elongated member 16 may be simply adhesively secured to the bottom of the cup-shaped portion of the body 11. Further, the closure membrane may have artificial stroma 114 on either or both sides and the flange 12 can be positioned along the cup-shaped body 11 rather than at the top thereof. Further, multiple flanges can be employed if desired. It is understood further that the intracorporeal portion of the elongated member 16 can include special structures for fixation, valves or other flow controlling mechanisms, branches or other arrangements for directing the flow, innercannulae or other irrigation mechanisms. it is to be further understood that the extracorporeal portion, for example, can be modified to incorporate structures such as skin plates, inner-cannulae, valves, and preparations which would facilitate connection or attachment to other extracorporeal devices. The entire device or any portion thereof may be prepared from radiopaque material to facilitate radiographic visualization of such a portion.

Particular examples of applications of the device described hereinabove include hemodialysis; peritoneal dialysis; percutaneous stoma communicating with the kidney, bladder, uretera, stomach, ileum, colon, or any other internal region or organ; percutaneous stoma for power lines needed to operate an internal artificial organ powered by an external source; electric wires and gas lines for an artificial source; and electric wires for artificial pacemakers and transducers. The device may be used also as a percutaneous stoma through which a metabolic product or byproduct can be repeatedly withdrawn. This applies to situations where repeated biopsies from an internal organ or system are indicated. it is useful as a percutaneous stoma through which an applicable medication or treatment can be administered. By use of fiber optics it is useful as a percutaneous window through which an organ or a system or their activities can be observed.

Other applications as well as modifications and variations of the embodiments described with particularity hereinabove will become obvious to those skilled in the art from a reading of the foregoing. it is therefore to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described.

That which is claimed is:

1. An artificial cutaneous stoma for percutaneous passage of an elongated body insertable member, comprising:

A generally cup-shaped body of surgically implantable material including a flange extending beyond the periphery of the cup-shaped portion,

tissue ingrowth means affixed to the external surface of said cup shaped body,

a flexible elongated body insertable member having an end portion thereof extending through the bottom of said body and the remainder thereof coiled within the cup-shaped portion thereof, and

a closure membrane closing the top of said cupshaped body whereby upon rupture or cutting of said membrane the coiled portion of said elongated member can be extended and withdrawn from said cup-shaped body while the artificial stoma is implanted.

2. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is a catheter.

3. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member includes an electrically conductive element.

4. An artificial cutaneous stoma as defined in claim 3 wherein said elongated member is a cardiac pacemaker lead.

5. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is a fiber optic element.

6. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is permanently affixed to the bottom of said cup-shaped body.

7. An artificial cutaneous stoma as defined in claim 1 wherein said cup-shaped member has a tubular member affixed to and extending from the bottom thereof and has another elongated member slidably positioned within said tubular member.

8. An artificial cutaneous stoma as defined in claim 1 wherein said closure membrane is peripherally adhered to the top surface of said flange.

9. An artificial cutaneous stoma as defined in claim 1 wherein the elongated member coiled within the cupshaped body has been exteriorized through the closure member and the cup-shaped body has been filled with a physiologically inert flexible material.

10. The artificial cutaneous stoma of claim 9 wherein the physiologically inert flexible material is a room temperature vulcanizable silicone rubber.

is t t 

1. An artificial cutaneous stoma for percutaneous passage of an elongated body insertable member, comprising: A generally cup-shaped body of surgically implantable material including a flange extending beyond the periphery of the cupshaped portion, tissue ingrowth means affixed to the external surface of said cup shaped body, a flexible elongated body insertable member having an end portion thereof extending through the bottom of said body and the remainder thereof coiled within the cup-shaped portion thereof, and a closure membrane closing the top of said cup-shaped body whereby upon rupture or cutting of said membrane the coiled portion of said elongated member can be extended and withdrawn from said cup-shaped body while the artificial stoma is implanted.
 2. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is a catheter.
 3. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member includes an electrically conductive element.
 4. An artificial cutaneous stoma as defined in claim 3 wherein said elongated member is a cardiac pacemaker lead.
 5. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is a fiber optic element.
 6. An artificial cutaneous stoma as defined in claim 1 wherein said elongated member is permanently affixed to the bottom of said cup-shaped body.
 7. An artificial cutaneous stoma as defined in claim 1 wherein said cup-shaped member has a tubular member affixed to and extending from the bottom thereof and has another elongated member slidably positioned within said tubular member.
 8. An artificial cutaneous stoma as defined in claim 1 wherein said closure membrane is peripherally adhered to the top surface of said flange.
 9. An artificial cutaneous stoma as defined in claim 1 wherein the elongated member coiled within the cup-shaped body has been exteriorized through the closure member and the cup-shaped body has been filled with a physiologically inert flexible material.
 10. The artificial cutaneous stoma of claim 9 wherein the physiologically inert flexible material is a room temperature vulcanizable silicone rubber. 